Packaging Engineer - San Francisco Area
Compli

Job Info

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Packaging Engineer - San Francisco Area

(Pharmaceutical/Biotech)-Competitive Salary, Work/Life Balance!

On-Site / Pay W-2

Previous Pharmaceutical/Biotech/Medical Device experience is mandatory for these roles.

Are you looking to be a part of a close-knit work community? Do you have experience in the Life Science industry? Will you represent Compli, LLC as an experienced Validation Engineer for our pharmaceutical manufacturing, biotech, and medical device client projects? Do you enjoy traveling the country and making a difference? If so, this could be the right opportunity for you!

The Validation Engineer I This position supports the establishment of a world-class packaging organization by providing technical expertise in the development and deployment of new packaging systems for pharmaceutical products and combination products. The selected candidate will work on a variety of packaging initiatives and will support Packaging Engineering in establishing packaging systems for clinical and commercial use.

Important: Our Client has mandated COVID-19 vaccination for their workforce, effective October 1st, 2021. All external personnel providing services to Compli' s client are required to comply with this requirement.

Responsibilities

• Develop and qualify global primary and secondary packaging solutions for sterile, non-sterile and combination products, incl. author/co-author the related packaging specifications and qualification documentation
• Qualification of global packaging solutions in line with the current validation requirements (e.g. Development of test protocols and reports, risk assessment, execute IQ/OQ/PQ, and shipping qualification)
• Maintenance of global packaging solutions (e.g. support change control records, provide impact assessments, execute requalification)
• Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or packaging systems based on product, regulatory, business or technical requirements
• Support or lead projects delivering innovative packaging technologies and systems under Roche global packaging technology centers

Technical Requirements

• Knowledge of packaging testing methodologies and standards including, shock, drop and vibration testing, peel force and tensile testing, barrier analysis, CCI/Sterile integrity, DIN, ISO, ISTA, USP, FDA, MHRA and ASTM standards for packaging design and validation
• Knowledge of packaging process equipment, related to steriles, non-steriles, and combination products packaging activities (e.g. vials, PFS, devices, aseptic form/fill/seal, blister and bottle filling lines), printing systems and serialization
• Knowledge on equipment IQ, OQ, and PQ and development of qualification protocols / reports for packaging and shipping qualification activities
• Knowledge of design control for combination products
• Working knowledge of computer systems including TOPS, CAD or Solid works, and Microsoft tools including MS project, and Adobe
• Knowledge of industry best practices and technical writing skills such as GMP and GDP

Education / Experience

• Bachelor degree, preferably with an engineering degree in packaging, materials science, or a related field
• At least 2 years' working experience in relevant field
• Proficient technical leadership, collaboration and communication skills
• English language proficiency required

Compli, LLC was founded in 2001 to provide commissioning, validation, and regulatory support services, CQV, asset management, reliability engineering, and staff augmentation services to the life sciences industry. We serve pharmaceutical companies across the U.S. Regarding regulations and compliance, it has never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction, and contractors, which is why clients trust the Compli team.

Perks of the Job:

• Competitive Pay commensurate with experience
• Work / Life Balance
• Working with a small, close-knit team where you are valued as an individual
• A learning environment and continuous advancement opportunities

Feel overqualified? Feel underqualified? Apply anyway if this sounds like the fit you are looking for! We have flexibility in how we hire the role.

To learn more and APPLY NOW: http://www.ucompli.com/careers

Agencies, Compli welcomes your qualified candidates. Please email compli-opportunities@ucompli.com to establish a relationship with our firm.

We are an equal opportunity employer M/F/D/V

Job Keywords: United States, South San Francisco, CA, CA, Surrounding Area, San Francisco, CA, California, Validation Engineer, Technical Writing, CQV

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